Study of Datopotamab Deruxtecan with or without Durvalumab compared to standard treatment for patients with Stage I-III triple-negative breast cancer who have remaining cancer after initial therapy
This study focuses on patients with Triple-negative Breast Cancer in stages I-III who have remaining disease after initial treatment before surgery. The main treatment being tested is Datopotamab deruxtecan (also known as Dato-DXd), which may be given alone or combined with another medication called Durvalumab. These will be compared to other standard treatment options that may include Capecitabine, Pembrolizumab, Infliximab, or Mycophenolate mofetil.
The purpose of this research is to determine if Datopotamab deruxtecan combined with Durvalumab works better than currently available treatments in preventing the cancer from returning after surgery. The medications being studied are given through an intravenous line directly into the bloodstream, except for Capecitabine and Mycophenolate mofetil which are taken as tablets by mouth.
During the study, participants will be randomly assigned to receive either Datopotamab deruxtecan alone, Datopotamab deruxtecan with Durvalumab, or one of the standard treatment options. The study will monitor how long patients remain free of cancer after starting treatment and track their overall health and well-being throughout the study period.
1Initial assessment and randomization
After completing neoadjuvant therapy (pre-surgery treatment) and surgery, you will be assigned to one of the treatment groups
The assignment occurs within 16 weeks after surgery if no radiation therapy is needed, or within 6 weeks after completing radiation therapy
2Treatment assignment
You will be assigned to receive one of these treatments:
– Datopotamab deruxtecan alone (given through intravenous infusion)
– Datopotamab deruxtecan combined with durvalumab (both given through intravenous infusion)
– Standard therapy chosen by your doctor (may include oral or intravenous medications)
3Regular health assessments
Your health status will be monitored through regular check-ups
Tests will include:
– Physical examinations
– Heart function monitoring
– Blood tests to check organ function
– Quality of life assessments using questionnaires
4Long-term follow-up
The study continues until August 2030
Regular monitoring will check for:
– Signs of disease return
– Side effects of treatment
– Overall health status
– Quality of life measures
5Study completion
The study ends if:
– The planned study period concludes
– The disease returns
– You develop significant side effects
– You choose to discontinue participation
Who Can Join the Study?
Must be at least 18 years old at screening
Have confirmed triple-negative breast cancer (a type of breast cancer that tests negative for certain hormones and proteins)
Have remaining cancer tissue in the breast and/or lymph nodes after initial treatment before surgery
Must have completed at least 6 cycles of initial chemotherapy containing specific drugs (anthracycline and/or taxane, with or without platinum chemotherapy or pembrolizumab)
Show no signs that cancer has spread to other parts of the body or returned locally
Had surgery to remove all visible cancer from breast and lymph nodes
Must provide a tissue sample from remaining cancer found during surgery
Have not started any additional treatment after surgery, except for radiation therapy if needed
If radiation therapy was given after surgery, must start the study within 6 weeks of completing radiation
If no radiation therapy was needed, must start the study within 16 weeks of breast surgery
Must not have known BRCA1 or BRCA2 gene mutations (specific inherited gene changes)
Have good organ function, including:
Adequate bone marrow function
Heart function of 50% or better
Be able to perform daily activities with minimal assistance (ECOG score of 0 or 1)
Who Cannot Join the Study?
Previous diagnosis of metastatic breast cancer (cancer that has spread beyond the breast and nearby lymph nodes)
History of other cancer within 5 years before starting the study, except for successfully treated non-melanoma skin cancer or cervical cancer in situ (early-stage cancer confined to the surface layer)
Significant heart problems including:
– Heart failure
– Heart attack within past 6 months
– Unstable heart rhythm disorders
– Poorly controlled high blood pressure
Active or untreated brain metastases (cancer spread to the brain)
Active autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
Current treatment with other experimental drugs or participation in another clinical trial
Known allergic reactions to study medications or their components
Active infections requiring treatment, including hepatitis B, hepatitis C, or HIV
Pregnant or breastfeeding women
Any condition that, in the opinion of the study doctor, would make participation unsafe
Datopotamab Deruxtecan (Dato-DXd) is an antibody-drug conjugate medication that specifically targets cancer cells in triple-negative breast cancer. It works by delivering a powerful anti-cancer drug directly to tumor cells, helping to destroy them while limiting damage to healthy cells.
Durvalumab is an immunotherapy medication that helps the body’s immune system recognize and fight cancer cells. It works by blocking a protein called PD-L1 that cancer cells use to hide from the immune system, making it easier for immune cells to find and destroy the cancer.
These medications are being studied together as a combination therapy for patients who still have some cancer remaining after receiving initial treatment (neoadjuvant therapy) and surgery for triple-negative breast cancer.
Triple-negative Breast Cancer – A type of breast cancer where the cancer cells lack receptors for estrogen, progesterone, and HER2 protein. It typically starts in the breast tissue when normal cells begin to grow abnormally, forming a mass or tumor. This cancer tends to grow and spread more quickly than other types of breast cancer. The disease can affect the breast tissue, potentially spreading to nearby lymph nodes and other parts of the body. Triple-negative breast cancer accounts for about 10-15% of all breast cancers and can occur at any age.
Residual Invasive Disease – A condition where cancer cells remain in the body after initial treatment. It refers to the presence of remaining cancer cells that can be detected in tissue samples after a patient has received pre-surgical (neoadjuvant) therapy. The residual disease indicates that some cancer cells survived the initial treatment, though they may be fewer in number than before treatment began.
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